Introduction
"Quality and safety above everything". That is the unassailable theme that guides everything that we do, every day. We have an unwavering commitment to quality and the production of safe and effective products. Our science and risk-based compliant quality culture is innovative, and healthcare oriented. Whether you are involved in development, operations, maintenance, compliance or analysis, through research and manufacturing programs, your contribution will directly impact our success.
Your Diligence Means Our Success
At Pherros, we combine development and safety to improve the lives of those around us. Our employees bring life-changing medicines to people in need and improve the understanding and management of disease. We give our best to putting people first and we are looking for people who are determined to improve life for everyone.
You will be a member of Pherros' dedicated and highly effective quality control operations team. Our aseptic manufacturing facility for parenteral pharmaceuticals presents an exciting opportunity to be an important part of a state-of-the-art facility and quality system. The Quality Control Laboratory assures patients worldwide that our drug products are safe and effective and of the highest quality and integrity. We exceed these standards through effective execution of process, environmental, supply and product testing.
General Requirements
As a Quality Control Chemist, you will perform accurate and timely testing of routine and non-routine samples in accordance with appropriate Good Manufacturing Practices ("GMP"), Good Laboratory Practices ("GLP"), and safety guidelines, to support site production and stability requirements.
The Chemist and Chemistry Supervisor roles are focused on the quality control testing of the various pharmaceutical products manufactured at Pherros Biosciences. All testing performed is in accordance with the established drug product specifications. The candidate will participate in and perform development and validation of analytical test methods associated with finished dosage form (FDF) drug products as well as investigate, resolve, and mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with products tested at the facility. The Quality Control Scientist utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results. Additional key objectives and deliverables include the capability to:
- Be an inspirational part of a vibrant and growing group of professionals.
- Accurately and safely perform timely testing of routine and non-routine lab samples in accordance with appropriate GMP, GLP, and safety guidelines.
- Accurately record data in reports or Laboratory Information Management System ("LIMS") in accordance with laboratory procedures, Good Laboratory Practices ("GLP"), standards, and GMP requirements.
- Recognize deviations from procedures, methods, etc., and initiate an investigation as required.
- Verify analytical data generated by other analysts within the lab as required.
- Adhere to all Environmental, Health, and Safety ("EH&S") standards.
- Identify and communicate opportunities for improvement initiatives in daily work activities.
- Troubleshoot equipment and methods as required.
- Provide technical support for non-routine (e.g., deviation) investigations.
- Maintain inventory of all supplies and consumables for the laboratory.
- Gown for activities within aseptic manufacturing suites typical of a GMP environment.
- Engage in training exercises to fulfill compliance requirements associated with the position.
- Conduct chemical and physical testing of raw materials, API, in-process, finished products, and stability samples, and other in process samples, using established test methods to provide accurate and reliable data to assure their strength, identity and purity.
- Work with materials using safe protocols and participate in and contribute to the maintenance and calibration of analytical instruments within the quality control laboratories.
- Collaborate with other facility team members and regulatory colleagues to establish release and stability specifications for starting materials, intermediates, drug substances, and drug products.
- Work well in a fast-paced team environment.
- Collaborate with management to identify training needs and ensure appropriateness of training plans, creating and assigning curricula as required.
- Contribute to the training, education, guidance, and influence of operational and support areas on quality control policy and practices.
- Foster a culture of collaboration, partnership, teamwork, and a drive for change and continuous improvement.
- Take initiative and have the ability to work independently as well as collaboratively with exemplary enthusiasm amongst other team members.
- Perform other duties as assigned.
Educational, Experience and Training Requirements
Bachelors, Masters or Ph.D. degree in Chemistry with three (3) to seven (7) years of relevant experience in a GMP Chemistry Lab environment, including knowledge of analytical chemistry testing, excellent understanding and knowledge of analytical instrumentation technologies, chromatography methods, USP compendial test methods, ICH guidelines, and cGMP, experience with HPLC and LCMS analytical testing, method development, and method validation is required, experience with GCMS, FTIR and ICPMS is required for supervisors, strong communication and organizational skills, proficiency in Microsoft Office suite applications (Excel, Word, PowerPoint), ability to handle multiple tasks simultaneously while meeting deadlines, ability to investigate, collect data, and analyze trends investigations, ability to work as needed for off-hours stability timepoints and potential early start times, excellent communication (written and verbal), interpersonal, organizational and negotiation skills, project management skills, experience in process improvement, and the ability to be solution focused on the design and implementation of quality and process improvements.
Additional Preferences:
Experience with a LIMS system.
Ability to lead and to inspire others.
Experience with a Quality Management System ("QMS") such as Master Control.
Demonstrated problem solving and analytical thinking skills.
Understanding of statistical tools and analysis.
Excellent interpersonal skills and networking skills.
Experience in a GMP QC Lab environment.
Demonstrated written and verbal communications skills.
Strong attention to detail.
Ability to organize and prioritize multiple tasks.
Experience with Root Cause Analysis.
Demonstrated ability to work both independently and as a part of a team.
Additional Information
The position is full-time non-remote, Monday through Friday, with flexibility to support weekends. Applicants will work in various areas within the site. Some allergens may be present in the facility. Exposure to allergens should be considered when applying for this position. Tasks may require repetitive motion (e.g., keyboarding). Minimal travel required.
Sunshine Act
Pherros reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pherros to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pherros intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pherros that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pherros is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pherros also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Quality Control
About Us
Careers at Pherros Biosciences are like no other. We believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community in order to bring innovative therapies to market and to make the world a healthier place.